BODY FLUIDS BARRIER KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMERGENCY RESPONSE SAFETY KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MYSET PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

ANY PLUS SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ANI BIOCARD(TM) HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENI BLOOD UREA NITROGEN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SIDE-FIRING UROLOGIC REFRACTIVE FIBER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UROTEK RE-USABLE FIBEROPTIC CABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3M QUIKPLUS SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

UROTEK LASER CATHETER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UROTEK LASER CATHETER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HandX™ Monopolar Scissors

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ORTHODONTIC CERAMIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP

FDA 510(k)

FDA Class 2 ·Ophthalmic

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology